MAUDE Adverse Event Report: BECTON DICKINSON BD DISCARDIT¿ SYRINGE; PISTON SYRINGE

Catalog Number 302438

Device Problems Leak/Splash (1354); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/20/2022

Event Type  malfunction  

Event Description

It was reported that 331 bd discardit¿ syringes from lot: 1184817, and 37 syringes from lot: 1313818 has issues with blister leakage.This complaint was created to capture the 3rd of 4 related incidents.The following information was provided by the initial reporter: "rejection details for 2ml syringes * 25g x 1¿ needle ¿ quantity 43,935 pcs , product code#: 302438".

Manufacturer Narrative

The manufacturing location for this product is (b)(4), india.This site is not registered with the fda.Therefore, bd corporate headquarters in (b)(4) has been listed in manufacturer name, city and state and mfr site and the (b)(4) fda registration number has been used for the manufacture report number.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1184817, medical device expiration date: 30-jun-2026, device manufacture date: 03-jul-2021, medical device lot #: 1313818, medical device expiration date: 31-oct-2026, device manufacture date: 09-nov-2021.Investigation summary: there are no samples and 17 photograph along with the reported complaint of multiple defects.The investigating team has used the retention samples of material number: 302438 and lot number: 1184817, 1313818 for investigating the reported defect.The investigation and simulation were carried out on ten retention samples where the investigating team has visually tested the samples for multiple defects and no multiple defects was found in the ten retention samples.The following actions are work in progress: blister damage- for blister damage chain issue was identified and leading to laminate holding thus causing cutting issues.Chain replaced and frequency set to replace chain after every three years.All the actions above will be monitored for effectiveness check for the period of 6 months and reviewed by the oqc team in the weekly oqc meeting.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.

• Brand Name: BD DISCARDIT¿ SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15249197
• MDR Text Key: 305417919
• Report Number: 2243072-2022-01367
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 302438
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2022
• Initial Date FDA Received: 08/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1